TXA in kids undergoing scoliosis surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled study evaluating two intravenous TXA dosing regimens against placebo in children undergoing posterior spinal fusion for idiopathic scoliosis. Participants are randomly assigned to receive either a TXA bolus with continuous infusion, two TXA bolus doses, or saline, with neither patients nor clinicians knowing the assignment. The primary outcome is perioperative blood loss, while secondary outcomes include transfusion requirements, laboratory changes, and safety events such as seizures or thrombosis, followed up to 30 days post-surgery. All procedures follow standardized anesthesia, regional analgesia, and intraoperative neuromonitoring per institutional protocols. The trial aims to clarify optimal TXA use in this pediatric surgical setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 10 to 18 years
* Diagnosis of idiopathic scoliosis requiring surgical correction (posterior spinal fusion)
* American Society of Anesthesiologists (ASA) physical status I-II
* Written informed consent from parents or legal guardians and assent from the child

Exclusion Criteria:

* Congenital or acquired coagulopathy
* History of thromboembolic disease
* History of seizures or epilepsy
* Known hypersensitivity to tranexamic acid
* Renal insufficiency (estimated glomerular filtration rate \< 60 mL/min/1.73 m²)
* Cardiac arrhythmias or cardiovascular disease requiring antiplatelet or anticoagulant therapy

Where it's running

• Poznan University of Medical Sciences
  Poznan, Poland Recruiting

Study contacts

• Study coordinator: Malgorzata Reysner, MD PhD
• Email: mreysner@ump.edu.pl
• Phone: +48 61 831-01-22

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.